Completed

NCT Number: NCT01255189

Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants

Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the effect of positional changes on cerebral oxygenation in preterm infants.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

pOSitional Changes of Premature Infants

Age range

3 day–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gamze Demirel

Ankara, Turkey (Türkiye)

About this study

The changes in cerebral perfusion have an important role on the development of intraventricular hemorrhage and periventricular leucomalacia. Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the effect of positional changes on cerebral oxygenation in preterm infants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

<32 gestational age and/or <1500gr.
>30th day preterm infants

Exclusion criteria

sepsis
shock
severe intracranial hemorrhage
NEC
abdominal and cranial surgery

Treatment and study plan

Device: near infrared spectroscopy: INVOS 5100

Device

NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.

Other names: invos 5100

invos 5100

Device

near infrared spectroscopy: invos 5100

Primary outcomes

The effect of positional changes on cerebral oxygenation in preterm infants

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Registry information

Official study title

Measurement of the Effect of Positional Changes on Cerebral Oxygenation in Preterm Infants: A Near Infrared Spectroscopy Study

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Dec 7, 2010
Registry last updated: Aug 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.